Spirometer mouthpiece

ABSTRACT

A disposable mouthpiece and flexible bag which are adapted to be connected with a spirometer or spirometer interface. The mouthpiece is completely surrounded by the flexible bag with a major portion of said bag being inserted within the bore of the mouthpiece for shipping. In use the bag is forced from the bore of the mouthpiece into an interface device or spirometer.

United States Patent 1 1 Klohr July 3I,-I973 I SPIROMETER MOUTIIPIECE[75] Inventor: Robert E. N. Klohr, Fenton, Mo.

[73] Assignee: Sherwood Medical Industries Inc.,

St. Louis, Mo.

[22] Filed: Feb. 16, 1972 [21] Appl. No.: 226,954

Related US. Application Data [63] Continuation of Set, bio/881,836, Dec.3, 1969,

abandoned.

[52] US. Cl. 128/2.08, 206/632 A [5]] Int. Cl A6lb 5/08 [58] Field ofSearch I28/2.08, 145.5, 128/272, 262, 349; 46/88, 90; 206/632 R, 63.2 A

[56] References Cited UNITED STATES PATENTS 1,098,222 5/1914 Brasefield128/262 3,512,521 5/1970 Jones I28/2.U8 3,333,844 8 1967 JurschakI28/2.08 ux 3,457,920 7/1969 Thompson.... 128/1455 x 3,421,509 1 1969Fiore 128/349 3,505,996 4 1970 Cowley 128/I45.8

FOREIGN PATENTS OR APPLICATIONS 303,252 10/1968 Sweden 206/632 R PrimaryExaminer- Kyle L. Howell Attorney Donald S. Olexa et al.

57 ABSTRACT A disposable mouthpiece and flexible bag which are adaptedto be connected with a spirometer or spirometer interface. Themouthpiece is completely surrounded by the flexible bag with a majorportion of said bag being inserted within the bore of the mouthpiece forshipping. In use the bag is forced from the bore of the mouthpiece intoan interface device or spirometer.

3 Claims, 12 Drawing Figures SPIROMETER MOUTHPIECE This is acontinuation of Ser. No. 881,836, filed Dec. 3, 1969, now abandoned.

BACKGROUND OF THE PRESENT INVENTION Spirometers are known in the art tobe devices which provide a visual representation of the patientsexpiratory cycle in volume.

Generally, spirometric devices include an expandable chamber carrying amarking stylus. Movable in timed relation to the expandable chamber in adirection transverse to the stylus movement is a record upon which thestylus records a graph representing air volume. In the past tubing wasprovided from the expandable chamber directly to a mouthpiece into whichthe patient exhales.

There are several disadvantages in these prior constructions, a primaryone being that the patient contaminates the expandable chamber orbellows within the spirometer and since this chamber or bellows is notdesigned to be removed after each use there arises a probability oftransferring a communicable disease, such as tuberculosis, to anotherpatient using the spirometer. Another disadvantage in these priorconstructions is that the mouthpiece itself, into which the patientexhales, may become contaminated after use by a patient.

A primary object of the present invention is to provide an interface fora spirometer with a disposable mouthpiece that eliminates contaminationof the spirometer and reduces the likelihood of mouthpiececontamination.

SUMMARY OF THE PRESENT INVENTION In accordance with the presentinvention a spirometer is provided with an interface between thespirometer bellows and the patient to prevent the direct exhalation ofthe patients air into the spirometers bellows. The interface deviceincludes a rigid plastic interface chamber having one end connectedthrough flexible tubing to the spirometer bellows.

The other end of the rigid interface chamber has an opening whichreceives a disposable mouthpiece and flexible interface wallcombination. The disposable mouthpiece consists ofa tubular member whichduring manufacture is inserted within a clear flexible plastic bag withthe bag thereafter being sealed closed. The tubular member is thenshifted to one corner of the bag and the bag is held contiguous with theoutside of the tubular member. Thereafter holes are pierced in thecorner of the bag covering the central opening of the tubular member andthe free end of the bag is evacuated and inserted within the interior ofthe tubular member. It is in this condition. that the tubular member andthe flexible interface wall are shipped to the physician.

When it is desired that a patients spirogram be taken, a new mouthpieceand interface wall combination is inserted as a unit into the rigidinterface chamber with the end of the tubular mouthpiece into which thebag was inserted pointing into the chamber. The projecting end of themouthpiece, which is covered by one corner of the'plastic bag at thattime, is then further opened and rolled back exposing a contaminationfree mouthpiece for the patients use. Thereafter, the portion of theflexible container within the mouthpiece is forced into the rigidinterface chamber either by a finger or a plunger or even by a short,quick breath. The spirometer interface is thus ready for the patientsuse. As the patient exhales into the mouthpiece the flexible containerexpands inside the rigid interface chamber forcing contamination freeair therefrom into the spirometers bellows eliminating contaminationthereof.

There are several advantages to this construction in addition to thoseset forth above. One is that the combined mouthpiece and interface wallnot only eliminates contamination of the spirometer but through itscompact size resulting from the novel method of manufacture,significantly reduces handling cost and facilitates use by thephysician. An additional advantage is that due to the fact that thepresent mouthpiece is completely encased in the interface wall containerduring manufacture the likelihood of contamination thereof issignificantly reduced since the mouthpiece is not completely uncovereduntil ready for use by the patient.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of aspirometer having an interface device in accordance with the presentinvention;

FIG. 2 is a cross section of a mouthpiece according to the presentinvention with a portion of the flexible interface wall shown;

FIG. 3 is a perspective view of the mouthpiece being inserted into aflexible plastic container which will form the interface wall;

FIG. 4 is a perspective view of the tubular mouthpiece within theflexible container;

FIG. 5 is a perspective view of the mouthpiece being shifted to a cornerof the flexible container;

FIG. 6 is a perspective view of the mouthpiece and container beinginserted within a die for the purpose of holding the container againstthe sides of the mouthpiece;

FIG. 7 is a perspective view of the container being inserted within themouthpiece;

FIG. 8 is a perspective view of the container with a major portionthereof being inserted within the tubular member;

FIG. 9 is a perspective view of the mouthpiece and container in its formready to be shipped to the physician;

FIG. 10 is a fragmentary section showing the mouthpiece and containerinserted within a rigid interface chamber;

FIG. 11 is a partial fragmentary view showing the portion of thecontainer within the mouthpiece being forced therefrom into the rigidinterface chamber; and

FIG. 12 is a perspective view showing a patient exhaling into themouthpiece with the container expanding within the rigid interfacechamber.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The cycle of thespirometer is generally initiated by the application of fluid underpressure through conduit ll into the bellows (not shown). As the patientexha'les, air is forced through conduit 11 into the bellows expandingthe bellows and at the same time the record 18 is moved with respect toa stylus carried by the bellows providing a tracing 19 on the recordrepresenting the air volume per unit time during the expiratory cycle ofthe patient. As is well known, this information is useful in thediagnosis of many diseases.

The primary purpose of the interface device 13 is to preventcontamination of the bellows within the spirometer by isolating thepatients air from the air delivered to the bellows through conduit 11.

Toward this end the interface device 13 is seen to include a spheroidshaped rigid plastic container 22 defining an interface chamber 24 asseen more clearly in FIG. 12. Handles 26 and 27 may be provided on theopposite sides of the container to facilitate patient use. Themouthpiece and interface wall combination 16 is adapted to bemanufactured as a separate disposable item, shipped to the physician,used for one patient and then discarded. Since the interface wall itselfis disposed of along with the mouthpiece, contamination of the bellowsin the spirometer as well as cross contamination between patient areminimized.

As seen in FIG. 2 the mouthpiece and interface wall combination 16 isseen to include a stepped tubular mouthpiece 30 of cylindricalconstruction which may be constructed of a suitable plastic material,such as polyethylene. The tubular mouthpiece 30 has an enlarged portion32 insertable within the interface chamber 22 and an elongated reducedportion 33 which projects from the interface chamber 22 and is adaptedto be inserted within the patients mouth.

An important aspect of the present invention is the method ofmanufacture of the disposable mouthpiece and interface wall 16 shown inits completed form in FIG. 9 ready for shipment to the using physician.Referring to FIG. 3 the tubular mouthpiece 30 is inserted into a threeclosed side generally rectangular, flexible, plastic container 36. Theopen end of the container, represented generally at 37 in FIGS. 3 and 4is then heat sealed thereby completely encasing the mouthpiece 30 withinthe container.

The mouthpiece 30 is then manipulated within the container 36 so thatthe reduced end 33 opens toward one corner represented generally at 39in FIG. 5.

Thereafter, the portion of the container 36 adjacent the mouthpiece 30is held against the outside of the mouthpiece. At this time several pinholes are punched into the corner of the bag adjacent the reducedportion opening as indicated at 46 in FIG. 7. The purpose of these pinholes is to permit evacuation of the container 36 but they are smallenough to minimize the possibility of any contamination of themouthpiece 30 during shipment to the physician. The mouthpiece 30surrounded by the container 36 is then inserted, reduced end first, intoan assembly fixture 42 having an opening therein 43 approximately thediameter of the enlarged portion 32 of tubular mouthpiece 30. As themouthpiece is forced into the opening 43 the container is pulled uparound the periphery of and in contiguous engagement with the outside ofthe mouthpiece 30.

With the mouthpiece 30 and the container 36 projecting through fixture42 a vacuum is applied to the reduced portion 33 of the mouthpiece in amanner to evacuate substantially all the air from container 36. With theassistance of a suitable plunger mechanism (not shown) the largeoverhanging portion of the container 36 is inserted within the interiorof the mouthpiece through the opening of the enlarged portion 32. Uponremoval of mouthpiece and container combination 16 from the fixture 42it is ready for packaging and shipment in its form shown in FIG. 9.

When received by the using physician, the mouthpiece and containercombination 16 is still in the form shown in FIG. 9 and remains so untilready for use by a patient. When it is desired that the spirometer beused a mouthpiece and interface wall combination 16 is inserted withinopening in the rigid interface housing 22 with the enlarged portion 32of the mouthpiece projecting into the chamber 24 and the reduced portion33 projecting from the interface housing 22. The end of the containercovering the opening of the reduced portion 33 is punctured and strippedback to expose a clean mouthpiece tube portion. As shown in FIG. 11 afinger, or alternatively, a plunger or a quick breath of air, is used toforce the bag or the container 36 from within the mouthpiece 30 andthereafter the interface device is ready for use.

As seen in FIG. 12 a patient is exhaling into the mouthpiece portion 33expanding the container 36 within the chamber 24. The container 36defines a flexible interface wall for interface device 13, forcing airin the left side of the chamber 24 through flexible conduit 11 into thebellows associated with spirometer 10. After use the mouthpiece 30 iswithdrawn from the interface housing 22 bringing with it the container36 and both are then discarded.

I claim:

1. A disposable mouthpiece for use with either a spirometer or aspirometer interface chamber having an outlet adapted to be connected toa spirometer, comprising an elongate tubular mouthpiece, one end ofwhich is adapted to be inserted into an inlet opening of the spirometeror interface chamber and the other end of which is adapted to bereceived in the mouth ofa patient, and a flexible gas impervious bagcompletely surrounding said tubular mouthpiece, a major portion of saidbag being inserted within the bore of said tubular mouthpiece.

2. A disposable mouthpiece as defined in claim 1 wherein said bag has atleast one small aperture therein, said aperture being located in aportion of said bag adjacent the end of said tubular mouthpiece adaptedto be received in the mouth of a patient.

3. A disposable mouthpiece as defined in claim 1 wherein said bag is ofgenerally rectangular configuration and the tubular mouthpiece is withinthe bag at one corner thereof, said one corner having at least one smallaperture therein to facilitate air removal from said bag.

* k I I

1. A disposable mouthpiece for use with either a spirometer or aspirometer interface chamber having an outlet adapted to be connected toa spirometer, comprising an elongate tubular mouthpiece, one end ofwhich is adapted to be inserted into an inlet opening of the spirometeror interface chamber and the other end of which is adapted to bereceived in the mouth of a patient, and a flexible gas impervious bagcompletely surrounding said tubular mouthpiece, a major portion of saidbag being inserted within the bore of said tubular mouthpiece.
 2. Adisposable mouthpiece as defined in claim 1 wherein said bag has atleast one small aperture therein, said aperture being located in aportion of said bag adjacent the end of said tubular mouthpiece adaptedto be received in the mouth of a patient.
 3. A disposable mouthpiece asdefined in claim 1 wherein said bag is of generally rectangularconfiguration and the tubular mouthpiece is within the bag at one cornerthereof, said one corner having at least one small aperture therein tofacilitate air removal from said bag.